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A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH
Description:
Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.
Sponsor:
BayerContacts:
Bayer Clinical Trials Contactclinical-trials-contact@bayer.com
(+)1-888-84 22937
Government Study Link:
NCT04597125 - Click here to see study onClinicalTrials.gov
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Locations
Australia 🇦🇺
Gosford, New South Wales, Australia
North Tamworth, New South Wales, Australia
Randwick, New South Wales, Australia
St Leonards, New South Wales, Australia
Wollongong, New South Wales, Australia
Auchenflower, Queensland, Australia
Brisbane, Queensland, Australia
Southport, Queensland, Australia
Tugun, Queensland, Australia
Adelaide, South Australia, Australia
North Adelaide, South Australia, Australia
Penrith, New South Wales, Australia
Castle Hill Road, Castle Hill New South Wales 2154, Australia
Austria 🇦🇹
Upper Austria, Austria
Vienna, Austria
Czech Republic 🇨🇿
Brno, South Moravian, Czech Republic
Chomoutov, Olomouc, Olomouc, Czech Republic
Liberec, Liberec, Czech Republic
Olomouc, Olomouc, Czech Republic
Praha, Prague, Czech Republic
Czech Republic
Praha, Prague, Czech Republic
Praha, Prague, Czech Republic
Finland 🇫🇮
Helsinki, Uusimaa, Finland
Kuopio, Northern Savonia, Finland
Oulu, Northern Ostrobothnia, Finland
33520, Tampere, Pirkanmaa, Finland
France 🇫🇷
Besançon, Doubs, France
Bordeaux, Gironde, France
Bordeaux, Gironde, France
Brest, Finistère, France
Caen, Calvados, France
Créteil, Val-de-Marne, France
Dijon, Côte-d’Or, France
Grenoble, Isère, France
Hyères, Var, France
Lille, Nord, France
Lyon, Rhône, France
Marseille, Bouches-du-Rhône, France
Montpellier, Hérault, France
Nice, Alpes-Maritimes, France
Reims, Marne, France
Rennes, Ille-et-Vilaine, France
Strasbourg, Bas-Rhin, France
Toulouse, Haute-Garonne, France
Tours, Indre-et-Loire, France
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Villejuif, Val-de-Marne, France
Germany 🇩🇪
Münster, North Rhine-Westphalia, Germany
Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Free Hanseatic City of Bremen, Germany
Kreis Göttingen, Lower Saxony, Germany
Hong Kong 🇭🇰
Hong Kong
Hong Kong
Hong Kong
Hong Kong
Hong Kong
Shatian Qu, Hong Kong
Hungary 🇭🇺
Budapest, Hungary
Budapest, Hungary
Debrecen, Hajdú-Bihar, Hungary
Szekszárd, Tolna, Hungary
Szolnok, Jász-Nagykun-Szolnok, Hungary
Israel 🇮🇱
Haifa, Haifa District, Israel
Haifa, Haifa District, Israel
Holon, Tel Aviv District, Israel
Jerusalem, Jerusalem District, Israel
Petah Tikva, Central District, Israel
Tel Aviv-Yafo, Tel Aviv District, Israel
Italy 🇮🇹
Napoli, Naples, Italy
Ferrara, Italy
Modena, Italy
Parma, Italy
Reggio Emilia, Italy
Pordenone, Italy
Rome, Italy
Genoa, Italy
Milan, Italy
Alessandria, Italy
Pisa, Italy
Trentino, Italy
Terni, Italy
Padua, Italy
Lithuania 🇱🇹
Kaunas, Lithuania
Klaipeda City, Lithuania
Vilnius, Lithuania
Vilnius, Lithuania
Poland 🇵🇱
Powiat Bydgoski, Kuyavian-Pomeranian Voivodeship, Poland
Kielce, Świętokrzyskie Voivodeship, Poland
Koszalin, West Pomeranian Voivodeship, Poland
Krąków, Powiat Sieradzki, Łódź Voivodeship, Poland
Lublin Voivodeship, Poland
Warszawa, Masovian Voivodeship, Poland
Wrocław, Lower Silesian Voivodeship, Poland
Russia 🇷🇺
Chelyabinsk, Russia
Samara, Russia
Moscow, Russia
Обнинск, Kaluga, Russia
Omsk, Russia
Tomsk, Russia
Singapore 🇸🇬
Singapore
Singapore
South Korea 🇰🇷
Goyang-si, Gyeonggi-do, South Korea
Seongnam-si, Gyeonggi-do, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Spain 🇪🇸
Santiago de Compostela, A Coruña, Spain
Cádiz, Spain
Oviedo, Asturias, Spain
Badalona, Barcelona, Spain
Palma, Balearic Islands, Spain
Majadahonda, Madrid, Spain
A Coruña, Spain
Barcelona, Spain
Barcelona, Spain
Castellón, Spain
Girona, Spain
Jaén, Spain
Lugo, Spain
Madrid, Spain
Málaga, Spain
Valencia, Spain
Taiwan 🇹🇼
高雄市, Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Türkiye 🇹🇷
Ankara, Türkiye
Adana, Türkiye
Istanbul, Türkiye
Karşiyaka, Basiskele, Kocaeli, Türkiye
İzmir, Türkiye
Istanbul, Türkiye
İzmir, Türkiye
İzmir, Türkiye
Kayseri, Türkiye
Gaziantep, Türkiye
Ankara, Türkiye
Istanbul, Türkiye
Istanbul, Türkiye
Istanbul, Türkiye
Edirne, Türkiye
Istanbul, Türkiye
United Kingdom 🇬🇧
Reading, England, United Kingdom
Greater London, England, United Kingdom
Preston, Lancashire, England, United Kingdom
Guildford, Surrey, England, United Kingdom
Glasgow City, Scotland, United Kingdom
